21-47 High Street, Feltham, Middlesex, TW13 4UN, UK ISO/IEC 17021:2011 to provide quality management systems Head Office Warwick House Houghton Hall Park Houghton Regis Dunstable LU5 5ZX Contact: Mr S Russell Tel: +44 (0)1582 539 000 Fax: +44 (0)1582 539 090 E-Mail: enquiries@ascertiva.com Website: www.ascertiva.com Locations where activities covered by the above Accreditation Standard are undertaken Shanghai NQA Certification Co Ltd Room 15-1 985 Dongfang Road Pudong New Zone Shanghai 200122 People s Republic of CHINA Ascertiva Group Limited trading as NQA Warwick House Houghton Hall Park Houghton Regis Dunstable LU5 5ZX UNITED KINGDOM Lead Office for EN 9104-001:2013 Aerospace Sector Scheme NQA USA inc 4 Post Office Square Road Acton MA 01720 USA Assessment Manager: TM Page 1 of 11
European Co-operation for Accreditation DETAIL OF ACCREDITATION ISO 9001:2008 Certification /Limited Accreditation EA 1 Agriculture, fishing EA 2 Mining and quarrying EA 3 Food products, beverages and tobacco EA 4 Textiles and textile products EA 5 Leather and leather products EA 6 Wood and wood products EA 7 Pulp, paper and paper products EA 8 Publishing companies EA 9 Printing companies EA 10 Manufacture of coke and refined petroleum products EA 12 Chemicals, chemical products and fibres EA 13 Pharmaceuticals EA 14 Rubber and plastic products EA 15 Non-metallic mineral products Assessment Manager: TM Page 2 of 11
European Co-operation for Accreditation ISO 9001:2008 Certification /Limited Accreditation EA 16 Concrete, cement, lime, plaster etc EA 17 Basic metals and fabricated metal products, including of scrap metal recovery in accordance with European Regulation EU/333/2011 EA 18 Machinery and equipment EA 19 Electrical and optical equipment EA 20 Shipbuilding EA 21 Aerospace EA 22 Other transport equipment EA 23 Manufacturing not elsewhere classified EA 24 Recycling, including of scrap metal recovery in accordance with European Regulation EU/333/2011 EA 25 Electricity supply EA 26 Gas supply EA 27 Water supply EA 28 Construction Assessment Manager: TM Page 3 of 11
European Co-operation for Accreditation ISO 9001:2008 Certification /Limited Accreditation EA 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods EA 30 Hotels and restaurants EA 31 Transport, storage and communication EA 32 Financial intermediation; real estate; renting EA 33 Information technology EA 34 Engineering services EA 35 Other services Including contract maintenance of portable fire extinguishers in accordance with BAFE SP101. EA 36 Public administration EA 37 Education EA 38 Health and social work EA 39 Other social services END Assessment Manager: TM Page 4 of 11
IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Non-active Medical Devices General non-active, nonimplantable medical devices Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active medical devices with measuring function (1) Non-active ophthalmologic devices (2) Non-active instruments Contraceptive medical devices (3) Non-active implants Non-active orthopaedic implants Non-active functional implants (4) Devices for wound care Bandages and wound dressings Suture material and clamps Other medical devices for wound care Non-active dental devices and accessories Non-active dental devices/equipment and instruments Dental products Dental implants Non-active medical devices other than specified above (5) Assessment Manager: TM Page 5 of 11
IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Active Medical Devices (Non-Implantable) General medical devices Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices Devices for stimulation or inhibition Active surgical devices Active Opthalmologic devices Active dental devices Active devices for sterilisation and disinfection Active rehabilitation devices and prostheses Active devices for patient positioning and transport Software Devices for imaging Devices Utilising ionizing rays Monitoring devices Monitoring devices of nonvital physiological parameters Monitoring devices of vital physiological parameters Devices for radiation therapy and thermo therapy Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia/hypothermia Devices for (extracorporal) shockwave therapy (lithotripsy) Active (non-implantable) medical devices other than specified above Assessment Manager: TM Page 6 of 11
IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Active Implantable Medical devices General active implantable medical devices Active implantable medical devices for stimulation / inhibition Active implantable medical devices delivering drugs or other substances Active implantable medical devices substituting or replacing organ functions Implantable medical devices other than specified above Sterilisation Method for Medical devices Ethylene oxide gas (EOG) Moist heat Aseptic processing Radiation sterilisation (e.g. gamma, x-ray, electron beam) Sterilisation other than specified above In Vitro Diagnostic Medical Devices (IVD) In Vitro Diagnostic Instruments and software Assessment Manager: TM Page 7 of 11
IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area In Vitro Diagnostic Medical Devices (IVD) (cont d) Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Haematology /Haemostasis /Immunohematology Immunochemistry Microbiology Infection Immunology Histology/cytology Genetic Testing IVD medical Devices other than specified above Devices incorporating/utilising specific substances/technologies Medical devices incorporating medicinal substances Medical devices utilising tissues of animal origin Medical devices incorporating derivatives of human blood Medical devices utilising micromechanics Medical devices utilising nanomaterials Assessment Manager: TM Page 8 of 11
IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Devices incorporating/utilising specific substances/technologies (cont d) Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed END Sector Scheme Accreditation NATO Codification TickIT TickIT Plus Foundation Level Aerospace Sector Certification Scheme Lead Office for EN 9104-001:2013 Aerospace Sector Scheme Warwick House Houghton Hall Park Houghton Regis Dunstable LU5 5ZX UNITED KINGDOM EN 9104-001:2013 for the of clients to AS, EN or JISQ 9100 and AS, EN JISQ 9120 ISO 9001 Application Documents PAS 43: 2002 - Safe working of vehicle breakdown and recovery operators Assessment Manager: TM Page 9 of 11
National Highway Sector Schemes Design and/or Supply, Installation and Repair of Fences - Highway Sector Scheme No 2A Supply, Installation and Repair of Vehicle Restraint Systems - Highway Sector Scheme No 2B Design, Supply, Installation and Repair of Environmental Barriers (Structural) - Highway Sector Scheme No 2C Manufacture of Parapets for Road Restraint Systems - Highway Sector Scheme No 5A Installation of Parapets for Road Restraint Systems - Highway Sector Scheme No 5B Manufacture and Verification of Lighting Columns - Highway Sector Scheme No 6 Application of Road Marking Materials and Road Studs to Road Surfaces - Highway Sector Scheme No 7 Installation and Maintenance of Highway Electrical Equipment and Road Traffic Signs - Highway Sector Scheme No 8, 9B & 10 Traffic Sign Manufacture - Highway Sector Scheme No 9A Static Temporary Traffic Management on Motorways and High Speed Dual Carriageways Including On Line Widening Schemes - Highway Sector Scheme No 12A & 12B Mobile Lane Closure Traffic Management on Motorways and Other High Speed Dual Carriageways - Highway Sector Scheme No 12C Installing, Maintaining and Removing Temporary Traffic Management on Rural and Urban Roads - Highway Sector Scheme No 12D Supply and Application of Surface Dressing to Road Surfaces - Highway Sector Scheme No 13A Supply and Application of Microsurfacing - Highway Sector Scheme No 13B Quality Management of the Production of Asphalt Mixes - Highway Sector Scheme No 14 Supply of Paving Grade Bitumen - Highway Sector Scheme No 15 Laying of asphalt mixes - Highway Sector Scheme No 16 For Vehicle Recovery at Highway Construction Sites (17) and Vehicle Recovery and Removal on Control Roads (17B) National Highway Sector Scheme 17/17B Natural Environment and Landscape, including Ecology - National Highway Sector Scheme 18 Corrosion protection of ferrous materials by industrial coatings - Highway Sector Scheme No 19A END Assessment Manager: TM Page 10 of 11
Ascertiva Group Limited Trading as NQA is recorded as issuing UKAS accredited certificates to organisations in the countries listed below. This list is current at the time of issue of this schedule. Austria Ascension Islands Argentina Bahrain Belgium Belize Brazil Cyprus Commonwealth of Dominica Czech Republic Denmark Egypt Finland France Germany Greece Grenada Holland Hong Kong Hungary India Indonesia Ireland Italy Israel Jamaica Japan Jordan Korea Kuwait Luxembourg Malaysia Mongolia Norway Pakistan Peoples Republic of China Qatar Russia Serbia and Montenegro Singapore Slovak Republic South Africa Spain Sweden Switzerland Taiwan The Netherlands Antilles Thailand Trinidad Turkey United Arab Emirates United Kingdom United States of America Uzbekistan Vietnam West Indies Yemen Assessment Manager: TM Page 11 of 11